Notification of standard update –  Significant changes from CAN/CGSB-43.125-1999 to CAN/CGSB-43.125-2016

The Canadian General Standards Board updated the CAN/CGSB-43.125 standard. Since the last revision of this standard 17 years ago, no less than nine editions of the Recommendations on the Transport of Dangerous Goods, Model Regulations (UN Model Regulations) have been published. The CAN/CGSB-43.125-1999 was based on the 10th edition and the CAN/CGSB-43.125-2016 is based on the most up to date edition of the UN Model Regulations (19th edition).

This document summarizes the most significant changes to the standard that are applicable to manufacturers of packagings for Category A and Category B infectious substances. Not all changes to the standard are covered here.

It is the responsibility of the a manufacturer of Type P620 (formerly Type 1A) and/or Type P650 (formerly Type 1B) packagings or a user of packagings for Category A and Category B, infectious waste or biomedical waste to read and understand the sections of the standard that are applicable to their respective activities, to ensure that they are aware of all the changes.

For Manufacturers of packagings of Category A and Category B infectious substances

For Users of packagings of Category A and Category B infectious substances and biomedical waste

For Manufacturers of packagings of Category A and Category B infectious substances

Updating the terminology

The terminology used in the CAN-CGSB-43.125 standard has changed. In the 2016 edition,

  • ‘Type 1A packaging’ has been replaced by ‘Type P620 packaging’, which refers to packing instruction P620 of the UN Model Recommendations,
  • ‘Type 1B packaging’ has been replaced by ‘Type P650 packaging’, which refers to packing instruction P650 of the UN Model Recommendations, and
  • ‘Type 1C packaging’ has been removed in the new standard.

A Type 1A packaging is not only used for transporting Category A infectious substances as the terminology would suggest.  It can also be used to transport Category B infectious substances and biomedical waste.

Similarly, a Type 1B packaging can be used to transport Category B infectious substances, but also Category A infectious substances in a form other than a culture or substances that do not meet subsection 2.36 (3) of the Transportation of Dangerous Goods Regulations and biomedical waste. 

Finally, a Type 1C container is the least intuitive term since there are no Category C infectious substances.  This container can be used to transport Category A (if not meeting subsection 2.36 (3) of the Transportation of Dangerous Goods Regulations) and Category B infectious substances intended for disposal and biomedical waste.

Type P620 packagings

There were no major changes made to the requirements applicable to Type P620 packagings (formerly Type 1A packagings) in the 2016 edition when compared to the 1999 edition. A few modifications were required to align with the UN Model Regulations.

The most noteworthy change for Type P620 packagings is how they are registered with Transport Canada.

Registration (section 10)

The way in which Transport Canada issues registrations for Type P620 packagings will change going forward. In the future, when a new registration is issued or an existing one renewed:

  • The certificate will be issued to the manufacturing facility under the number 42-XXX.
  • The certificate will list all the manufacturer’s registered designs in an appendix. There will be no changes to the compliance markings (UN marking strings) as the design registration numbers will not change (8-XXX).
  • The new certificates will be valid for 5 years instead of the current 3 years.

All current registrations remain valid until their expiry.

This will streamline the application and record keeping processes as all designs held by a manufacturer will be found on the same Certificate of Registration and have the same expiry date. Only one renewal application will need to be submitted and only one Certificate of Registration will need to be documented.

Type P650 packagings

Compliance marking (Section 5.2)

The compliance marking ‘TC-125-1B’ has been replaced by ‘UN3373’ found in packing instruction P650 of the UN Model Regulations to harmonize with applicable international transportation regulations.  The UN3373 marking is considered to be a hybrid marking since it is already used as a dangerous good safety mark in the Transportation of Dangerous Goods Regulations. Consequently, a new provision will also be added in the Transportation of Dangerous Goods Regulations to allow the dangerous good mark, UN3373, to be displayed on an empty container as the mark also serves as a compliance mark under the new standard.

Testing (Section 7 and Table 2B)

Performance requirements

The CAN/CGSB-43.125-99 standard does not contain performance requirements for Type 1B packagings (now Type P650) as they are currently included in the Transportation of Dangerous Goods Regulations (95 kPa internal pressure test and the 1.2m drop test).  These requirements set out in section 5.16.1 of the Transportation of Dangerous Goods Regulations will be repealed, as they are now covered in the 2016 edition of the standard.

Internal pressure testing exemption for road shipment

In the 1999 edition, regardless of the mode of transport, the primary receptacle or the secondary packaging must be capable of withstanding an internal air pressure or pressure differential of not less than 95 kPa. This requirement can also be found in the UN Model Regulations. However, a review of 49CFR (section 173.199) shows that packagings for Category B infectious substances transported by road do not have to meet the 95 kPa internal pressure testing requirement as set out in the UN Model Regulations.

The requirement for 95 kPa internal pressure testing is not considered a reasonable requirement for ground transport given there is minor change in internal pressure with ground transportation compared to air transport. Given that some trans-border shipments of laboratory specimens do occur, compatibility between the US and Canadian regulatory systems is desirable to minimize confusion between laboratories when coordinating shipments. Therefore, the requirements in CAN/CGSB-43.125-2016 deviate from the UN Model Regulations and do not require the 95 kPa internal pressure test for packagings intended for ground transport.

For users of packagings of Category A and Category B infectious substances and biomedical waste

It is recommended to read the sections of the standard applicable to you to ensure you are aware of all the changes.

Updating the terminology

  • ‘Type 1A packaging’ has been replaced by ‘Type P620 packaging’, which refers to packing instruction P620 of the UN Model Recommendations,
  • ‘Type 1B packaging’ has been replaced by ‘Type P650 packaging’, which refers to packing instruction P650 of the UN Model Recommendations, and
  • ‘Type 1C packaging’ has been removed in the new standard.

A Type 1A packaging is not only used for transporting Category A as the terminology would suggest.  It can also be used to transport Category B infectious substances and biomedical waste. 

Similarly, a Type 1B packaging can be used to transport Category B infectious substances but also Category A infectious substances in a form other than a culture or substances that do not meet criteria 2.36 (3) in Transportation of Dangerous Goods Regulations and biomedical waste. 

Finally, a Type 1C container is the least intuitive term since there are no Category C infectious substances.  This container can be used to transport Category A (if not meeting subsection 2.36 (3) of the Transportation of Dangerous Goods Regulations) and Category B infectious substances intended for disposal and biomedical waste.

Introducing selection and use requirements

The selection and use requirements for packagings for infectious substances and biomedical waste have been moved from section 5.16 of the Transportation of Dangerous Goods Regulations to the 2016 edition of the CAN/CGSB-43.125 standard.

The selection and use requirements are now covered in two new parts found in the 2016 edition of CAN/CGSB-43.125:

  • Part II of will cover the selection and use of packagings for infectious substances of Category A and Category B and
  • Part III will cover the selection of packagings for the transport of infectious substances of Category A and Category B intended for disposal and biomedical waste

Extending the selection of means of containment for waste

The container selection for waste will be aligned with the UN Model Regulations and it will allow the use of large packagings meeting the requirements of Chapter 6.6 of the UN Model Regulations. However, non-specification containers permitted in the 1999 edition will still continue to be permitted in the 2016 edition.

Date modified: